QA Supervisor (Wuhan)
- Principal Duties and Responsibilities Participate in the daily activities of the QA Department as assigned.
- Establish and maintain quality system to ensure the manufacture, testing and distribution processes comply with applicable regulatory requirements.
- Lead or participate in the internal auditing program for JHL Wuhan China, as required. Also supporting regulatory, client and third party supplier audits.
- Lead or participate in the execution of the product compliant system and assist with product return, withdrawal or recall activities as required.
- Oversee compliance of the environmental monitoring and validation program.
- Operational execution of key elements of the quality system-including document control, change control, CAPA, to maintain compliance with GMP and international regulatory requirements.
- Writing or reviewing completed quality system documents.
- Provide QA input on GMP facility and GMP utilities issues such as qualifications/requalification, changes, maintenance, startup/shutdown, disaster recovery.
- Writing or reviewing validation protocols such as IQ, OQ and PQ to support new production equipment installation.
- Review and approval of data for determining the disposition of GMP material (raw material, in-process, drug substance, finished product, packaging, labeling and manufacturing components) and the review and approval of documents and data associated with the stability program.
- Conduct GMP training for internal functional department.
Job Qualifications (Education, Certifications, Experience)
- BS degree and above, scientific discipline preferred.
- At least 5 years experience in a quality regulated industry, pharmaceutical or medical device experience is preferred, QC experience and regulatory submission experience in China is a plus.
- At least 2 years in a GMP quality system QA role.
- Proficiency in the use of all Microsoft office applications.
- Demonstrated leadership experience with personnel management, development and accountability
- Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines. Well organized and detail oriented professional.
- In-depth knowledge of GMPs and related guidelines and regulatory requirements.
- Good oral and written communication skills in English and Mandarin. (Read, Write, Verbal) demonstrated by communicating effectively with other functions and management processes within quality assurance and multi-disciplinary teams.